Professional Documents
Culture Documents
bacteria 0/1 g
- Salmonella sp. 0/1 g
- Escherichia coli 0/1 g
- Staphylococcus aureus 0/1 g
- Pseudomonas aeruginosa 0/1 g
* 95.0 - 102.5 % at re-testing
RESULT: Product has been manufactured in accordance with principles of GMP as
detailed in ICH Guideline Q7A
Product conforms to the specification in SBR0380K/03, App. No. 1
Note: product conforms to the specification in USP 34 and Microbial testing
of product conforms to the specification in Ph. Eur. 7, harmonised method
Authorized Person Date:
(pursuant to EudraLex 4/II, 2.14 & 2.22.1)